Dawood Subhani Page * of *

Dawood Subhani MD

Cell: 909-***-****

ad23m1@r.postjobfree.com

Summary

More than 10 years of clinical research experience working in both office practice, SMOs, CROs and in institutions such as USC, UCSC, VA SFO, collaborated research/clinical trials with reputed universities like Stanford, Harvard Universities.

RESEARCH ACTIVITIES

Certification in Clinical Research Associate from Physis Global Academy. Certification in Clinical Trial Design and Management from University of California Santa Cruz Extension. Supervised and managed many site qualifications, initiation, monitoring, and termination visits. Thorough understanding of the process and ability to execute independently.

Major Areas of Research Topics: Neurology, Multiple Sclerosis, Headache, Anemia associated with CKD, Pediatric asthma and immunology, and Gastroenterology.

Published more than 15 papers on various topics from HIV, emergency medicine, multiple sclerosis, headache etc. Worked in eCTD documents submitting FDA. Understand and can managed eTMF and CTMS sponsor applications. Expertise in Oracle clinical, InformEDC, Medidata, ePRO, Bioclinica, Veeva and other sponsors applications. Sophisticated in technical aspects of applications. Experienced in Windows office applications. Deeper scientific background ability to communicate opinion leaders and do scientific presentations. Experience in IRB submission. FDA submission using eCTD format. Experienced in study budgets. PROFESSIONAL EXPERIENCE

Alpha Oncology Research, Orlando, Florida Jan 2023- Current Clinical Site Manager: Primary responsibility site is recruitment for 3 sites with over 40 different protocols mainly in oncology and few in GI studies. Verification of Inclusion and exclusions. Supervise, Advise and guide other CRC to complete all study related activities like Obtain informed consent, Obtain medical history, Inclusion/exclusion criteria verification, Perform vital signs, Phlebotomy, IV infusion, Perform ECG, AE/SAE assessment and reporting, Mentoring and Monitoring patients, eCRF entry, Query resolution, EDC, IP assignment in IVTS/IWRS, Dispense IP, IP receipt/ return paperwork, IP accountability and reconciliation, Lab samples collection and processing, Maintaining Investigator Site file, Non drug supplies reconciliation. Trained several staffs. Care access Research, Orlando, Florida Dec 2020- Dec 2022 Clinical Site Manager: Managed GI studies with 2 support staff for 13 different studies. Manage study related activities like Obtain informed consent, Obtain medical history, Inclusion/exclusion criteria verification, Perform vital signs, Phlebotomy, IV infusion, Perform ECG, AE/SAE assessment and reporting, Mentoring and Monitoring patients, eCRF entry, Query resolution, EDC, IP assignment in IVTS/IWRS, Dispense IP, IP receipt/ return paperwork, IP accountability and reconciliation, Lab samples collection and processing, Maintaining Investigator Site file, Non drug supplies reconciliation. Trained several staffs.

Pedz Care, Orlando, Florida Aug 2020- Dec 2020

House Physician: Set up clinic with local and state approval. Setting up EMR.Complete Insurance eligibility. Obtaining and recording patient’s history and performing focused physical examinations and recording all the components of SOAP notes. Billing and Coding pertinent to relevant diagnosis. Kidz and Family Care, Altamonte Springs, Florida July 2018- Dec 2020 House Physician: Obtaining and recording patient’s history and performing focused physical examinations and recording all the components of SOAP notes. Billing and Coding pertinent to relevant diagnosis. Sending the prescriptions electronically and resolving any issues with pharmacy. Completing the verification of insurance, referrals, refills and prior authorization. Prepare site for clinical trial activities. Participate in clinical management of the patients. Gutierrez-Perez Family Medicine Center, Kissimmee, Florida May 2017- July 2018 June 2019 to Feb 2020 Dawood Subhani Page 2 of 5

Clinical Project Manager: Epigene Channel: Wrote different component of Investigational New Drug (IND) Application and received IND Application number. Communicate regularly to get approval for the Phase 1 study. Wrote grant application to NIH. Wrote and collaborated for patent application with prior art searches and claims. Set up secure communication with the FDA and establishing webtrader account with FDA. Wrote protocol for sponsor-investigator initiated study to the FDA. Obtain ESG account and submitted document using eCTD format.

Researched and gathered medical evidence and developed rationale for the treatment. Develop database and charts to summarize the evidence for the clinical cases. Used excel and powerpoint to generate summarizing graphs and designed posters for venture capitalist funding. Set up biotech fund raising campaign with various entities. Involved and engaged community with different aspects of research. Communicated with Hedge fund manager and Investor to advance the research project. Communicated with different scientist in US and Europe in gathering information and developing New Chemical Entity.

Allergy Asthma Immunology and Wellness Institute, Kissimmee, Florida Dec 2016- Sep 2017 House Physician and Clinical Site Manager: Clinical care of Allergy Asthma and Immunology patient. History taking, general physical examination and perform laboratory work. Conduct and interpret different skin prick/scratch test and patch test. Setting clinic to clinical trial site as per GCP. Clinical Trial Site Development activities including contacting sponsors, CDA document completion and collaborating on SOP of site. Successfully set the site for expansion. Valley Renal Medical Group, Northridge, California Jan 2016- Nov 2016 Clinical Site Manager: Lead the several studies and assisted the team in others in all operation of Clinical research at the site.

Lead Clinical Research Coordinator: Complete all study related activities like Obtain informed consent, Obtain medical history, Inclusion/exclusion criteria verification, Perform vital signs, Perform ECG, AE/SAE assessment and reporting, Mentoring and Monitoring patients, eCRF entry, Query resolution, EDC, IP assignment in IVTS/IWRS, Dispense IP, IP receipt/ return paperwork, IP accountability and reconciliation, Lab samples collection and processing, Maintaining Investigator Site file, Non drug supplies reconciliation. Bayer 16208 and16209: A controlled, parallel group, open-label, multicenter extension study to investigate efficacy and safety of oral BAY 85-3934 and active comparator (epoetin alfa / beta) in the long-term treatment of subjects with anemia associated with chronic kidney disease who are on dialysis in the United States and Japan. GlaxoSmithKline: A Phase IIa, A 29-day, randomized, double-blinded, placebo-controlled, parallel-group, multi-center study to evaluate the efficacy, safety and pharmacokinetics of three-times weekly dosing of GSK1278863 in hemodialysis- dependent subjects with anemia associated with chronic kidney disease who are switched from a stable dose of an erythropoiesis-stimulating agent.

Fibrogen 060, 063 and 064 studies: A phase 3, Open-label, randomized, Active-controlled study of the efficacy and safety of Roxadustat (FG-4592) in the maintenance treatment of anemia in subjects with end stage kidney disease on stable dialysis

Credence/Janssen: A randomized, double blind, event-driven, placebo-controlled, multicenter study of the effects of canagliflozin on renal and cardiovascular outcomes in subjects with type 2 diabetes mellitus and diabetic nephropathy. Akebia Therapeutics, Inc. Protocol AKB-6548-CI-0014-0015 Superior Care Medical Center, Los Angeles, California Sept 2008 - Sept 2010, July 2013- Jan 2015 Evaluating the patients and writing the subjective objective assessment report. Assist in out patient medical and surgical procedures including surgical repair of skin laceration. Interpreting X rays and common labs. Experienced in worker comp patients. Training the staff. Worked updating electronic medical records in the office practice. Setting the practice for expansion. Communicating with the insurance companies and other vendors. Manage the overall practice. Marketing different company for the services at the facility. LAC and USC, Los Angeles, California Dec 2009 – July2013 Lead Clinical Research Coordinator

Comparison of Monthly Pulse ACTH (ActharGel) Therapy with Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif). Sponsor: Questcor Pharmaceuticals Inc

PI: Regina Berkovich MD PhD

http://clinicaltrials.gov/ct2/show/NCT01049451

Responsibilities

Ensure Clinical Trial Protocol followed.

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Get timely assessment for research subjects from Clinicians.

Complete Clinical Neurologic examination (EDSS) and all the study questionnaires.

Correspond with IRB for periodic submission of continuum review, SAE reporting, and maintenance of IRB binder. Arrange and facilitate periodic IRB site visit.

Designed study database, analyze the data and generate report to produce scientific abstract.

Collaborated with Stanford University in completing Material Transfer Agreement for the transfer immunologic samples for processing.

Collaborated with Harvard University team to share MRI of the study subject in periodic manner.

Present study updates to the Department Multiple Sclerosis team.

Facilitated opinion leaders in the field of Neurology for the scientific presentation.

Communicated with Questcor Pharmaceuticals to receive periodic study drug sample and maintain corresponding logs. Arrange for the sponsor site-monitoring visit. Pilot Study for Evaluation of Glatiramer Acetate in RRMS Patients with Autoimmune Comorbid Conditions Responsibilities

Wrote initial study protocol after conducting extensive literature search on medical Journals on relevant topics.

Involved the sponsor and USC HRA in budget negotiation and successfully worked towards approval.

Submitted initial IRB application and follow through continuously for approval and maintenance of study validity till competition

Complete Clinical Neurologic examination and all the study questionnaires.

Designed study database, analyze the data and wrote manuscript for publication.

Submission of periodic report in the Teva Pharmaceutical studies database for continuous update.

Present study updates to the Department Multiple Sclerosis team. Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients

(STRIVE)

Role: Communication with the sponsor in setting up the site for initiation of clinical trial, facilitating the process of site selection, budget negotiation between sponsor and USC budget office (CRO), getting IRB approval, Neurology Department approval, and USC MS Care approval. Visited the sponsor for receiving training in screening subjects and running the study. The Questcor study and GA for MS study projects were completed and delivered on schedule. University of California, San Francisco, California Dec 2006 – Feb 2008 Research Fellow

PI: Matthew Lewin MD PhD

Collaborated in Updating chapters of Tintinalli’s Emergency Medicine Book. Medical writing skills were honed. Observing emergency medicine clinical practice.

VA Hospital, San Francisco, California Oct 2007 – Feb 2008 Clinical Research Associate I

PI: Sophia Vinogradov MD PhD

The Neuroscience-Guided Remediation of Cognitive Deficits in Schizophrenia Responsibilities included:

Evaluates and abstracts clinical research data from source documents especially fMRI and MEG scan data. Ensures compliance with protocol and overall clinical research objectives Completes Case Report Forms (CRFs). Works with a Clinical Research Coordinator to implement study Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors Provides supervised patient contact or patient contact for long term follow-up patients only Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines

Assists with clinical trial budgets as needed

Assists with patient research billing as needed

Sri Ramakrishna Hospital, Bangalore, India Sept 2003 – Sept 2005 Resident Physician

Responsibilities included:

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• Hospital and clinical care of patients for acute and chronic conditions. My responsibilities included writing case report/progress notes of an inpatient, and also manage outpatients. Independently managed 20 patients in the hospital. Experienced in common medical procedures like taking/reading ECG, X-ray, lab report. Experienced in phlebotomy, paracentesis, thoracocentesis etc. Experienced in common surgical practice including suturing and assisting in surgery.

RESEARCH PAPERS

Berkovich, D. Togasaki, D. Subhani, L. Steinman. Dynamics of the peripheral blood CD4 cell counts of JCV Ab positive patients at the different phases of natalizumab treatment. ECTRIMS 2012 Leon, France. 2012 Jul;1(388R): 1. S

Guven Uzun, Dawood Subhani,Srikureja Amor, MD.. Trophic Factors and Stem Cells for Promoting Recovery in Stroke.. Journal of Vascular and Interventional Neurology. 2010 Mar; 3(1): 3-12. Cited in PubMed; PMID: 22518254.

Regina Berkovich, MD, PhD, Dawood Subhani, MBBS, Lawrence Steinman, MD. Autoimmune Comorbid Conditions in Multiple Sclerosis.US Neurology. 2011 Oct; 7(2): 132-8. Regina Berkovich, MD, PhD; Dawood Subhani, MD. Maura Fernandez, MD. Monthly pulse adrenocorticotropic hormone (ACTH) or methylprednisolone therapy for long- term treatment of multiple sclerosis as an add-on therapy to beta-interferons: interim results from a pilot study. ECTRIMS; Amsterdam, Netherlands. 2011 Oct; 1(1): 1.

Regina Berkovich, MD, PhD;; Dawood Subhani, Maura Fernandez. Adrenotrophic Hormone Treatment Of Multiple Sclerosis Exacerbations. International Journal of MS Care, CMSC,2012. 2012 May; Volume 14(Supplement 2,DX66): 66.

Soma Sahai-Srivastava MD, Dawood Subhani MBBS. Factors associated with presence of tender trigger points on shoulder girdle muscles in Occipital neuralgia. The 15th Congress of the International Headache Society; Berlin, Germany.. 2011 Jun; 1(1): 1.

Soma Sahai-Srivastava MD, Dawood Subhani MBBS.. Adverse Effect Profile of Lidocaine Injections for Occipital Nerve Block in Occipital Neuralgia.. 52nd Scientific Meeting of the American Headache Society; Los Angeles, CA. 2010 Jun; s(s): s.

Soma Sahai-Srivastava and Dawood Subhani. Adverse effect profile of Lidocaine injections for occipital nerve block in occipital neuralgia.. The Journal of Headache and Pain. 2010 Dec; 11(6): 519-523. Cited in PubMed; PMID: 20665065.

Williamson, Eric; Subhani, Dawood; Berkovich, Regina. Case Report: Progresive Encephelopathy In A Multiple Sclerosis Patient Responsive To Plasma Exchange, Including Magnetic Resonance Imaging. International Journal of MS Care, San Diego.. 2012 May; Volume 14,(Supplemen 2): 50. Peer Reviewed Book Chapter

Matthew R. Lewin, Subhani Dawood, Rina Shah. (2008). Asymptomatic Hypertension in the Emergency Department: First, Do No Harm. In Matthew R. Lewin (Ed.), Tintinalli's Emergency Medicine (pp. Section 7: Cardi). San Francisco, CA. McGraw Hill.

Oral Presentation to USC MS Care:

Neuronal Regeneration: Retinoic acid and signaling pathways. PowerPoint presentation to MS GROUP on Sept 28,2012.

Therapeutic Plasma Exchange in Multiple Sclerosis: Current guidelines and past experiences, and a retrospective chart review. PowerPoint presentation to MS GROUP on Dec 7,2012. MEMBERSHIPS

Member of CMSC, Member of American Academy of Neurology Member of American Headache Society Alumni UCSC

Indian Medical Council (IMC), Karnataka Medical Council (KMC) EDUCATION

MBBS (MD): Rajiv Gandhi University of Health Sciences, Karnataka, India, Medical Council of India, 2004, License No. 7287

Clinical Research Design and Management Certification: University of California Santa Cruz, Cupertino, California, 2007

Diploma in Computer Automated Design Advanced Computer Institute, Los Angeles, California, 2010 Dawood Subhani Page 5 of 5

REFERENCES

Will be provided

Licensure

Florida Department of Health License Number: HSE24040 Rajiv Gandhi University of Health Sciences, Karnataka, India, Medical Council of India, 2004, License No. 7287

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